Nurse's RoleNCT04789083
The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study
A study testing Propholis extrate in people with Nurse's Role and Patient Education, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Tineapedis is an important health problem. Providing foot care in tinea pedis treatment contributes positively to the treatment. In addition, alternative treatments can also be used. In this study, the randomization study group will be divided into three. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Patient Education, Foot Care
- What is being tested?
- Propholis extrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2022to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not being pregnant
- Not being breastfeeding
- Not having confusion
- Not being immunosuppressed
- Not using systemic cortisone
- Not having any dermatological problems (psoriasis, contact dermatitis, etc.) that will affect the treatment.
Show all 10Show fewer
- Agree to participate in research
- Being accessible by phone
- Having no problems communicating by phone
- Not having problems with physical care
Who cannot join
- Pregnant / nursing women
- Using systemic antifungal therapy
- Using systemic croticosteroids
- In the process of treatment for oncological reasons
- Are using immunosuppressants
- Dermatological disease (contact dermatitis, psoriasis)
Show all 10Show fewer
- Under the age of 18 and over the age of 64
- Have cognitive problems
- There is no telephone / telephone number within reach
- Individuals who have difficulties in speaking and understanding Turkish will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Tineapedis is an important health problem. Providing foot care in tinea pedis treatment contributes positively to the treatment. In addition, alternative treatments can also be used. In this study, the randomization study group will be divided into three. Medical treatment and foot care training will be applied to the first group, medical treatment and propolis to the second group, medical treatment and plassebo to the control group. Foot care training will be given by nurse coaching. Times of all three groups and their response to treatment will be evaluated.
Read the detailed description
- Study Identification: Randomised Controlled Trial
- Study Status: This will begin
- Sponsor/Collaborators: SBS Scientific Bio Solutions Inc.
- Oversight: Patients will be given foot care training. At the same time, a phone call will be provided by the research nurse every week. Evaluation will be made at the end of 2 months
- Study Description It was planned as a double-blind randomized controlled study. The person conducting the randomizer, the person making the statistics and the person performing the medical examiner will be blinded. Power analysis was made using the G * Power (3.1.9.4) program, 0.05 margin of error and 85% power were accepted. A total of 96 people were divided into three groups. Groups were composed of 36 people, including 10% losses for each group. Inclusion Criteria: Not being pregnant Not being breastfeeding Not having confusion Not being immunosuppressed Not using systemic cortisone Not having any dermatological problems (psoriasis, contact dermatitis, etc.) that will affect the treatment. Agree to participate in research Being accessible by phone Having no problems communicating by phone Not having problems with physical care Exclusion Criteria: Pregnant / nursing women Using systemic antifungal therapy Using systemic croticosteroids In the process of treatment for oncological reasons Are using immunosuppressants Dermatological disease (contact dermatitis, psoriasis) Under the age of 18 and over the age of 64 Have cognitive problems There is no telephone / telephone number within reach Individuals who have difficulties in speaking and understanding Turkish will be excluded from the study. Medical treatment applied to all three groups: Sertaconazole nitrate (2%), 1x1, externally Terbinafine hydrochloride (250 mg), 1x1, oral Propolis treatment: Alcoholic extract of propolis will be used topically 2x1. Plassebe: Sterile distilled water 2x1 will be used. Plassebo and propolis extrat will be prepared in the same packages. Nurse coaching will continue by the nurse, who received coaching training, using the training booklet, with the first meeting face-to-face and subsequent calls over the phone. Interviews will be held once every two weeks.Each participant will be followed for two months. Their treatment and nurse coaching will also continue for two months. The nurse coach will coach each patient at least four times. Each coaching session will last at least 30 minutes. In the evaluation; Dermatological Quality of Life Scale will be used with the global evaluation of the patient and the doctor. Approval was obtained from Medipol University Traditional and Alternative Medicine Practices Ethics Committee for the research.
- Conditions and Keywords Propolis, foot care, nursing education
- Study Design: Randomised Controlled Trial
- Arms, Groups, and Interventions There are 2 experiments and 1 control group in the study. Routine antifungal therapy will be applied to all groups. Apart from this, one group will be given propolis, another group will be given plassebo. Another group will be given foot care training.
- Outcome Measures Doctor's global assessment Patient's global assesment Dermatological quality of life scale
- Eligibility The study was planned in accordance with the Turkish Ministry of Health rules.
- Contacts, Locations, and Investigator Information Rukiye Burucu Necmettin Erbakan Üniversitesi Seydişehir SBF Seydişehir/ Konya rburucu@hotmail.com 05062347525
- IPD Sharing Statement...
- Conditions
- Nurse's Role, Patient Education, Foot Care
- Being tested
- Propholis extrate
- Keywords
- nursing, nurse coaching, patient education, complementary therapy, althernative therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propholis extrateOther
Also called Nurse coaching/ Nursing education
Plassebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Propolis) | Experimental | Medical therapy and propolis Receives: Other: Propholis extrate |
| Group 2 (Nurse Coaching/ Nursing education) | Experimental | Medical treatment and nurse coaching Receives: Other: Propholis extrate |
| Group 3 (Plassebo) | Placebo comparator | Medical treatment and plassebo will be applied. Receives: Other: Propholis extrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation
Dermatological Quality of Life Scale
Measured: 3 month
Secondary outcomes (1)
Doctor's an patient's global
Doctor's global assessment
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start3 Feb 2022
- Primary completion19 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a double blind randomized controlled study
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Burucu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789083
- Sponsor's protocol ID
- NecmettinErbakanU-Burucu
- Status last verified
- Feb 2023
- First submitted
- 10 Dec 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04789083
- Acronym / sponsor ID
- NecmettinErbakanU-Burucu
- Conditions
- Nurse's Role, Patient Education, Foot Care
- Keywords
- nursing, nurse coaching, patient education, complementary therapy, althernative therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tineapedis is an important health problem. Providing foot care in tinea pedis treatment contributes positively to the treatment. In addition, alternative treatments can also be used. In this study, the randomization study group will be divided into three. Medical treatment and foot care training will be applied to the first group, medical treatment and propolis to the second group, medical treatment and plassebo to the control group. Foot care training will be given by nurse coaching. Times of all three groups and their response to treatment will be evaluated.
Detailed description
- Study Identification: Randomised Controlled Trial
- Study Status: This will begin
- Sponsor/Collaborators: SBS Scientific Bio Solutions Inc.
- Oversight: Patients will be given foot care training. At the same time, a phone call will be provided by the research nurse every week. Evaluation will be made at the end of 2 months
- Study Description It was planned as a double-blind randomized controlled study. The person conducting the randomizer, the person making the statistics and the person performing the medical examiner will be blinded. Power analysis was made using the G * Power (3.1.9.4) program, 0.05 margin of error and 85% power were accepted. A total of 96 people were divided into three groups. Groups were composed of 36 people, including 10% losses for each group. Inclusion Criteria: Not being pregnant Not being breastfeeding Not having confusion Not being immunosuppressed Not using systemic cortisone Not having any dermatological problems (psoriasis, contact dermatitis, etc.) that will affect the treatment. Agree to participate in research Being accessible by phone Having no problems communicating by phone Not having problems with physical care Exclusion Criteria: Pregnant / nursing women Using systemic antifungal therapy Using systemic croticosteroids In the process of treatment for oncological reasons Are using immunosuppressants Dermatological disease (contact dermatitis, psoriasis) Under the age of 18 and over the age of 64 Have cognitive problems There is no telephone / telephone number within reach Individuals who have difficulties in speaking and understanding Turkish will be excluded from the study. Medical treatment applied to all three groups: Sertaconazole nitrate (2%), 1x1, externally Terbinafine hydrochloride (250 mg), 1x1, oral Propolis treatment: Alcoholic extract of propolis will be used topically 2x1. Plassebe: Sterile distilled water 2x1 will be used. Plassebo and propolis extrat will be prepared in the same packages. Nurse coaching will continue by the nurse, who received coaching training, using the training booklet, with the first meeting face-to-face and subsequent calls over the phone. Interviews will be held once every two weeks.Each participant will be followed for two months. Their treatment and nurse coaching will also continue for two months. The nurse coach will coach each patient at least four times. Each coaching session will last at least 30 minutes. In the evaluation; Dermatological Quality of Life Scale will be used with the global evaluation of the patient and the doctor. Approval was obtained from Medipol University Traditional and Alternative Medicine Practices Ethics Committee for the research.
- Conditions and Keywords Propolis, foot care, nursing education
- Study Design: Randomised Controlled Trial
- Arms, Groups, and Interventions There are 2 experiments and 1 control group in the study. Routine antifungal therapy will be applied to all groups. Apart from this, one group will be given propolis, another group will be given plassebo. Another group will be given foot care training.
- Outcome Measures Doctor's global assessment Patient's global assesment Dermatological quality of life scale
- Eligibility The study was planned in accordance with the Turkish Ministry of Health rules.
- Contacts, Locations, and Investigator Information Rukiye Burucu Necmettin Erbakan Üniversitesi Seydişehir SBF Seydişehir/ Konya rburucu@hotmail.com 05062347525
- IPD Sharing Statement...
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a double blind randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Propolis) | Experimental | Other: Propholis extrateMedical therapy and propolis |
| Group 2 (Nurse Coaching/ Nursing education) | Experimental | Other: Propholis extrateMedical treatment and nurse coaching |
| Group 3 (Plassebo) | Placebo comparator | Other: Propholis extrateMedical treatment and plassebo will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Not being pregnant
- Not being breastfeeding
- Not having confusion
- Not being immunosuppressed
- Not using systemic cortisone
Key exclusion criteria (10 listed)
- Pregnant / nursing women
- Using systemic antifungal therapy
- Using systemic croticosteroids
- In the process of treatment for oncological reasons
- Are using immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propholis extrateAlso: Nurse coaching/ Nursing educationPlassebo | Other | Group 1 (Propolis), Group 2 (Nurse Coaching/ Nursing education), Group 3 (Plassebo) |
Primary outcome
Evaluation
Time frame: 3 month
Dermatological Quality of Life Scale
1 secondary outcome
Doctor's an patient's global
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propholis extrate in people with Nurse's Role and Patient Education, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.